FDA applicant
Koven and Assoc., Inc.
FDA records 8 decisions for Koven and Assoc., Inc. (St. Louis, MO) from 1989 to 1993: 8 510(k) clearances. Most are in product codes DPW (Flowmeter, Blood, Cardiovascular) and DXN (System, Measurement, Blood-Pressure…). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Koven and Assoc., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Koven and Assoc., Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Koven and Assoc., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Koven”
FDA records each applicant name separately; these may or may not be the same firm.